Clinical Practice Guidelines for the management of locally advanced ...

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105. Thompson IM, Tangen CM, Paradelo J et al. Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial. Journal of Urology 2009;181(3):956-962. 106. Wiegel T, Bottke D, Willich N et al. Phase III results of adjuvant radiotherapy (RT) versus "wait and see" (WS) in patients with pT3 prostate cancer following radical prostatectomy (RP) (ARO 96-02/ AUO AP 09/95). Journal of Clinical Oncology 2005;23(16S):4513. 107. Hocht S, Hinkelbein W. Postoperative radiotherapy for prostate cancer. Lancet 2005;366(9485):524-525. 108. Wiegel T, Bottke D, Willich N et al. Phase III results of adjuvant radiotherapy versus "wait and see" in patients with pT3 prostate cancer following radical prostatectomy (ARO 96-02/AUO AP 09/95). International Journal of Radiation Oncology Biology Physics, 2007. 109. Stephenson AJ, Scardino PT, Kattan MW et al. Predicting the outcome of salvage radiation therapy for recurrent prostate cancer after radical prostatectomy. J Clin Oncol 2007;25(15):2035-2041. 110. Van Cangh PJ, Richard F, Lorge F et al. Adjuvant radiation therapy does not cause urinary incontinence after radical prostatectomy: results of a prospective randomized study. Journal of Urology 159(1):164-6, 1998. 111. Moinpour CM, Hayden KA, Unger JM et al. Health-related quality of life results in pathologic stage C prostate cancer from a Southwest Oncology Group trial comparing radical prostatectomy alone with radical prostatectomy plus radiation therapy. Journal of Clinical Oncology 2008;26(1):112-120. 112. Lawton CA, Winter K, Grignon D, Pilepich MV. Androgen suppression plus radiation versus radiation alone for patients with stage D1/pathologic node-positive adenocarcinoma of the prostate: updated results based on national prospective randomized trial Radiation Therapy Oncology Group 85-31. Journal of Clinical Oncology 23(4):800-7, 2005. 113. Iversen P, Wirth MP, See WA et al. Is the efficacy of hormonal therapy affected by lymph node status? data from the bicalutamide (Casodex) Early Prostate Cancer program. Urology 63(5):928-33, 2004. 114. Granfors T, Modig H, Damber JE, Tomic R. Combined orchiectomy and external radiotherapy versus radiotherapy alone for nonmetastatic prostate cancer with or without pelvic lymph node involvement: a prospective randomized study. Journal of Urology 159(6):2030-4, 1998. 115. Granfors T, Modig H, Damber JE, Tomic R. Long-term followup of a randomized study of locally advanced prostate cancer treated with combined orchiectomy and external radiotherapy versus radiotherapy alone. Journal of Urology 176(2):544-7, 2006. 116. Bagshaw MA. Radiotherapeutic treatment of prostatic carcinoma with pelvic node involvement. Urologic Clinics of North America 1984;11(2):297-304. 117. Paulson DF, Cline WA, Jr., Koefoot RB, Jr., Hinshaw W, Stephani S. Extended field radiation therapy versus delayed hormonal therapy in node positive prostatic adenocarcinoma. Journal of Urology 127(5):935-7, 1982. 47 Locally advanced disease
4 BIOCHEMICAL RELAPSE A significant clinical problem both in terms of frequency and lack of data to provide guidance is the clinical scenario of patients with rising PSA levels and normal testosterone levels following definitive radiotherapy or radical prostatectomy. If the PSA rises following definitive local therapy (radical prostatectomy or radiation therapy), this is either due to residual prostatic cancer in the prostatic bed and/or pelvic or distant metastases. Very rarely it may be due to residual benign prostatic tissue. It also should be realised that after radiation therapy there may be an initial PSA rise (‘PSA bounce’) 1, 2 before PSA declines to a nadir, which can occur as late as two years following treatment. This is commonly seen after seed brachytherapy. The options for suspected prostate cancer recurrence following localised treatment to the gland with curative intent are further local treatment or systemic therapy in the form of androgen deprivation therapy (ADT). If ADT is going to be given, there is a question as to whether it should be started at the first evidence of PSA rise or when disease is evident with imaging. However, one must appreciate there are different patient groups in this setting. For example, patients with high-risk disease (and most with intermediate-risk disease) that have had definitive radiotherapy with curative intent will have had this in combination with hormonal therapy. In this situation, one needs to distinguish whether their progression is with a normal or castrate testosterone level. Another group will be hormone naïve and some of these patients (~20% of men over 60 years) may actually be hypogonadal due to testicular atrophy. 3 Some patients after prostatectomy may have received adjuvant radiation therapy and therefore differ to those who have not had prior radiation to the prostatic fossa. A rising PSA after radiation therapy is also a difficult problem to manage. Local therapy such as resection of the prostate after radiation or other procedures such as cryotherapy can also be considered. However, these are not routine and they have significant risks, such as furthering the chance of incontinence and impotence and, with procedures such as cryotherapy, of fistula (connections) between the bladder and rectum. It is recognised this a very complicated clinical situation with outcomes predicated by patients’ life expectancy, prior therapy and the innate biological characteristics of the cancer (rapid versus indolent). This situation also causes a lot of angst for patients. There are some patients with a very indolent course and the toxicity of early and prolonged ADT may be detrimental. 4.1 Salvage radiotherapy Patients who have not had prior radiation therapy are candidates for ‘salvage radiation’. These patients are often detected by a PSA rise post-prostatectomy. Salvage radiation is not an option for patients with prior definitive or adjuvant radiation. Unlike adjuvant radiation, there are no randomised phase III trials. The results of ‘salvage radiation’ are based on retrospective reviews and reported in terms of metastasis-free and overall survival. Patients with a lower PSA level at time of salvage radiation have a better chance of a longer PSA-free survival. 4 There are no randomised controlled data to define the benefits of salvage radiation versus adjuvant therapy or salvage radiation versus systemic therapy (either at time of PSA rise or at time of radiographic progression). The Trans-Tasman Radiation Oncology Group (TROG) is conducting a study of adjuvant radiation versus salvage therapy to help address this unanswered question. Clinical practice guidelines for the management of locally advanced and metastatic prostate cancer 48
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Clinical Practice Guidelines for th
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4 Biochemical relapse .............
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FOREWORD The management of prostate
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SUMMARY OF CLINICAL PRACTICE RECOMM
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SUMMARY OF RECOMMENDATIONS Chapter
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Chapter Recommendations Grade Refs
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Chapter Recommendations Grade Refs
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Page 20 and 21: 1 INTRODUCTION 1.1 Natural history
Page 22 and 23: 2 PSYCHOSOCIAL CARE The diagnosis a
Page 24 and 25: 2.2 Effect of psychological and cog
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Page 28 and 29: Recommendation Men with advanced pr
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Page 36 and 37: different treatments from different
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Page 42 and 43: Despite these reservations and the
Page 44 and 45: For non-metastatic disease there we
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Page 52 and 53: for surgery, suggesting that surger
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Page 60 and 61: of an international multicentre ran
Page 62 and 63: 45. Melton LJ, III, Alothman KI, Kh
Page 64 and 65: 76. Little DJ, Kuban DA, Levy LB, Z
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Page 72 and 73: therapy since such studies would be
Page 74 and 75: apparent in trials comparing CAB wi
Page 76 and 77: QLQ instrument published by Cleary
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Page 84 and 85: olus) in addition to radiotherapy a
Page 86 and 87: References 1. Seidenfeld J, Samson
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Page 90 and 91: Oncology Group, TROG 96.05). Radiot
Page 92 and 93: trial. European Journal of Cancer 1
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Page 100 and 101: with bone pain at study entry. At n
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Page 104 and 105: of these studies 56, 58 and in the
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Page 108 and 109: hydrocortisone respectively. Tannoc
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physiotherapists, occupational ther
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7.5 Q2: Symptom control There was e
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Informal or family caregivers deriv
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8. Hughes SL, Weaver FM, Giobbie-Hu
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8 COMPLEMENTARY AND ALTERNATIVE (UN
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corresponding benefit in obstructiv
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3. Eisenberg DM, Kessler RC, Van Ro
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areas of the state were more likely
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8 Miller DC, Litwin MS, Bergman J,
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10 EMERGING THERAPIES It is impossi
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APPENDIX 1 GUIDELINE DEVELOPMENT PR
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study type. Studies published befor
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Grade of recommendation Description
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2. National Health and Research Cou
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Dr Carole Pinnock AM Principal rese
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Surgery Professor Villis Marshall A
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APPENDIX 3 TNM CLASSIFICATION OF PR
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Summary Prostate T1 T2 T3 T4 N1 M1a
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APPENDIX 4 ABBREVIATIONS AND GLOSSA
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Glossary Actuarial survival A metho
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Effectiveness The extent to which a
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Lymph nodes Small, generally pea-si
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Each stage is divided into subgroup
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APPENDIX 6 - ORGANISATIONS WHICH PR
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Consultant Urologist, Royal Brisban
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No conflict of interest to declare.
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Index to Clinical practice guidelin
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cardiovascular mortality 19, 54, 55
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androgen deprivation therapy (ADT)
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and surgery 32-34 survival 18 toxic
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and chemotherapy 89-90 see also bon
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spinal cord compression 62-63 see a
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systemic 141 Tasmania Association f
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